Alcohol ConsumptionPhase 2NCT00219336
A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)
A Phase 2 study testing Self-guided Motivational Intervention and Informational Only in people with Alcohol Consumption and Fetal Alcohol Syndrome Disorders, run by Nova Southeastern University at 1 site in United States.
Trial summary
The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and non-students 18 to 44 years of age living in Florida. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Fetal Alcohol Syndrome Disorders, Students
- What is being tested?
- Self-guided Motivational Intervention and Informational Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 to 44 years who are not pregnant, not trying to become pregnant, and able to bear children.
- At risk for an alcohol exposed pregnancy 90 days prior to the interview defined as:
- had heterosexual vaginal intercourse with ineffective contraception
- not effectively using contraception
- drinking either ≥ 8 drinks per week on average or ≥ 5 drinks in a single day or both
- returned their informed consent and assessment materials within 60 days after it was mailed to them
Who cannot join
- No alcohol consumption or vaginal intercourse in the 90 days prior to the interview
- Pregnant
- Trying to become pregnant
- Not able to bear children
- Using contraception effectively
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University
Fort Lauderdale, Florida, 33314
About this study
Official title: A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs)
The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and non-students 18 to 44 years of age living in Florida. The investigators hypothesize that the motivational intervention will significantly reduce more women's risk of an AEP than will an informational intervention aimed at preventing fetal alcohol syndrome. Materials will be available in Spanish and English
Read the detailed description
The proposed project will evaluate the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) among students and non-students. Participants will be women 18 to 44 years of age who are at risk of an AEP. The community targeted will be the state of Florida. Materials were available in Spanish and English The intervention will be based on the investigators' previous experience in (a) promoting self-change of drinking behavior at a community level and (b) preventing reduced risk for AEP through the use of a motivational interventional materials used in Project CHOICES. Using a 2 group randomized design, the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The FAS prevention condition, a brochure developed by the CDC, served as the standard treatment control group in that most information available at the community level concerning the effects of alcohol on the developing fetus relate to FAS (e.g., warning labels on alcoholic beverage containers). It is suggested that many women, particularly college students, at risk for AEP do not view themselves as at risk for FAS and therefore do not view FAS-oriented prevention messages as personally relevant. The proposed experimental design will evaluate a mail-based strategy that could be easily implemented throughout communities. The proposed study design will have more methodological rigor and allow a more careful evaluation than would be possible if the intervention was initially targeted at the entire community. The follow-up will be the entire 6-months post-intervention.If successful, this low-cost intervention can be readily disseminated throughout the local area. Specific objectives are as follows:
- Develop an evidence-based intervention to reduce alcohol-exposed pregnancies that can be easily disseminated at a community level through the mail and other media outlets.
- Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs.
- Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS using the 3 primary outcome measures in previous Project CHOICES studies: (a) AEP reduced risk through reduced drinking or effective contraception, or both; (b) AEP reduced risk through drinking only; and (c) reduced risk through effective contraception only.
- Disseminate results of the study to health care providers in the local community.
- Being tested
- Self-guided Motivational Intervention, Informational Only
- Keywords
- Prevent Alcohol Exposed Pregnancies, Reduced Alcohol Used, Self-Guided Motivational Intervention, Effective Contraception, Contraception, College Students
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided Motivational InterventionBehavioural
Using a randomized two-group design, a self-guided motivational intervention based on Project CHOICES will be compared to an informational only intervention, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS.
Informational OnlyBehavioural
Using a randomized two-group design, an informational intervention using a brochure from the CDC will be compared to a self-guided motivational intervention based on Project CHOICES, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS
| Study group | Role | What they receive |
|---|---|---|
| Self-motivational Choices | Experimental | Students and nonstudents were mailed a brochure prepared as part of the PHC study intervention, Making Healthy Choices for a Healthy Baby in English or Mujeres y Salud Eligiendo Opciones Saludables in Spanish. This brochure allows women to make informed decisions about preventing an AEP. The MF materials included nonstigmatizing messages about drinking and contraception embedded among other health messages. Similar to Project CHOICES, this group also received a brochure on birth control practices. Receives: Behavioral: Self-guided Motivational Intervention |
| Information Only | Active comparator | Students and nonstudents were mailed a brochure prepared by the CDC. The brochure (English: Think Before You Drink: You Can Hurt Your Unborn Baby; Spanish: Piénselo Antes de Beber: Puede Lastimar a Su Futuro Bebe), available at the CDC website, targets women of childbearing-age, discusses FAS and the negative effects of a mother's drinking on her unborn child, and recommends calling Alcoholics Anonymous or an alcohol treatment program for help to stop drinking. The CDC brochure did not contain information about how to contracept effectively. Receives: Behavioral: Informational Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEP reduced risk through reduced drinking and effective contraception, or both
Not at risk if a women reported no risky drinking (see definition in outcome 2) or contracepting effectively, or both
Measured: 6 months post intervention
AEP reduced risk through reduced drinking only
Reduced risk drinking defined as ≤ 7 standard drinks (SDs) per week and ≤ 4 SDs on any day during the 6-month follow-up interval; 1 SD = 14 g absolute alcohol.
Measured: 6 months post intervention
AEP reduced risk through effective contraception only
The effectiveness of birth control methods was evaluated using algorithms (e.g., If you missed a pill during this time period, did you take both pills the next day and did you use a back up method other than rhythm or withdrawal until you started your next packet of pills?) from Project CHOICES
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionJul 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Linda Sobell, Nova Southeastern University
- Investigators
- Linda C Sobell, Ph.D., Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219336
- Sponsor's protocol ID
- U50/CCU300860
- Other IDs
- U50/CCU300860
- Status last verified
- Sep 2016
- First submitted
- 14 Sep 2005
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gioia CJ, Sobell LC, Sobell MB, Agrawal S. Craigslist versus print newspaper advertising for recruiting research participants for alcohol studies: Cost and participant characteristics. Addict Behav. 2016 Mar;54:24-32. doi: 10.1016/j.addbeh.2015.11.008. Epub 2015 Nov 19.
PubMed 26675247
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs)
- ClinicalTrials.gov ID
- NCT00219336
- Acronym / sponsor ID
- U50/CCU300860
- Keywords
- Prevent Alcohol Exposed Pregnancies, Reduced Alcohol Used, Self-Guided Motivational Intervention, Effective Contraception, Contraception, College Students
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and non-students 18 to 44 years of age living in Florida. The investigators hypothesize that the motivational intervention will significantly reduce more women's risk of an AEP than will an informational intervention aimed at preventing fetal alcohol syndrome. Materials will be available in Spanish and English
Detailed description
The proposed project will evaluate the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) among students and non-students. Participants will be women 18 to 44 years of age who are at risk of an AEP. The community targeted will be the state of Florida. Materials were available in Spanish and English The intervention will be based on the investigators' previous experience in (a) promoting self-change of drinking behavior at a community level and (b) preventing reduced risk for AEP through the use of a motivational interventional materials used in Project CHOICES. Using a 2 group randomized design, the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The FAS prevention condition, a brochure developed by the CDC, served as the standard treatment control group in that most information available at the community level concerning the effects of alcohol on the developing fetus relate to FAS (e.g., warning labels on alcoholic beverage containers). It is suggested that many women, particularly college students, at risk for AEP do not view themselves as at risk for FAS and therefore do not view FAS-oriented prevention messages as personally relevant. The proposed experimental design will evaluate a mail-based strategy that could be easily implemented throughout communities. The proposed study design will have more methodological rigor and allow a more careful evaluation than would be possible if the intervention was initially targeted at the entire community. The follow-up will be the entire 6-months post-intervention.If successful, this low-cost intervention can be readily disseminated throughout the local area. Specific objectives are as follows:
- Develop an evidence-based intervention to reduce alcohol-exposed pregnancies that can be easily disseminated at a community level through the mail and other media outlets.
- Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs.
- Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS using the 3 primary outcome measures in previous Project CHOICES studies: (a) AEP reduced risk through reduced drinking or effective contraception, or both; (b) AEP reduced risk through drinking only; and (c) reduced risk through effective contraception only.
- Disseminate results of the study to health care providers in the local community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-motivational Choices | Experimental | Behavioral: Self-guided Motivational InterventionStudents and nonstudents were mailed a brochure prepared as part of the PHC study intervention, Making Healthy Choices for a Healthy Baby in English or Mujeres y Salud Eligiendo Opciones Saludables in Spanish. This brochure allows women to make informed decisions about preventing an AEP. The MF materials included nonstigmatizing messages about drinking and contraception embedded among other health messages. Similar to Project CHOICES, this group also received a brochure on birth control practices. |
| Information Only | Active comparator | Behavioral: Informational OnlyStudents and nonstudents were mailed a brochure prepared by the CDC. The brochure (English: Think Before You Drink: You Can Hurt Your Unborn Baby; Spanish: Piénselo Antes de Beber: Puede Lastimar a Su Futuro Bebe), available at the CDC website, targets women of childbearing-age, discusses FAS and the negative effects of a mother's drinking on her unborn child, and recommends calling Alcoholics Anonymous or an alcohol treatment program for help to stop drinking. The CDC brochure did not contain information about how to contracept effectively. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 44 years who are not pregnant, not trying to become pregnant, and able to bear children.
- At risk for an alcohol exposed pregnancy 90 days prior to the interview defined as:
Key exclusion criteria (5 listed)
- No alcohol consumption or vaginal intercourse in the 90 days prior to the interview
- Pregnant
- Trying to become pregnant
- Not able to bear children
- Using contraception effectively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-guided Motivational InterventionUsing a randomized two-group design, a self-guided motivational intervention based on Project CHOICES will be compared to an informational only intervention, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS. | Behavioural | Self-motivational Choices |
| Informational OnlyUsing a randomized two-group design, an informational intervention using a brochure from the CDC will be compared to a self-guided motivational intervention based on Project CHOICES, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS | Behavioural | Information Only |
Primary outcome
AEP reduced risk through reduced drinking and effective contraception, or both
Time frame: 6 months post intervention
Not at risk if a women reported no risky drinking (see definition in outcome 2) or contracepting effectively, or both
AEP reduced risk through reduced drinking only
Time frame: 6 months post intervention
Reduced risk drinking defined as ≤ 7 standard drinks (SDs) per week and ≤ 4 SDs on any day during the 6-month follow-up interval; 1 SD = 14 g absolute alcohol.
AEP reduced risk through effective contraception only
Time frame: 6 months post intervention
The effectiveness of birth control methods was evaluated using algorithms (e.g., If you missed a pill during this time period, did you take both pills the next day and did you use a back up method other than rhythm or withdrawal until you started your next packet of pills?) from Project CHOICES
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Derived from this study: PubMed 26675247Gioia CJ, Sobell LC, Sobell MB, Agrawal S. Craigslist versus print newspaper advertising for recruiting research participants for alcohol studies: Cost and participant characteristics. Addict Behav. 2016 Mar;54:24-32. doi: 10.1016/j.addbeh.2015.11.008. Epub 2015 Nov 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda C Sobell, Ph.D. principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-guided Motivational Intervention and Informational Only in people with Alcohol Consumption and Fetal Alcohol Syndrome Disorders, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEP reduced risk through reduced drinking and effective contraception, or both (time frame: 6 months post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00219336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.